Uterine manipulator device

ABSTRACT

A uterine manipulator device for injecting a visualisation fluid into the uterine cavity of a female via the cervix. The device comprises an elongate body, a tanaculum for gripping the cervix and an inflatable bladder for forming a fluid-resistant seal with the cervix. The elongate body has a conduit along which visualisation fluid can be conveyed to the uterus and a conduit for air, having an outlet opening, which is connectable to a pressurized air supply. The bladder is mounted on the elongate body over the outlet opening, surrounding the elongate body and sealed to the elongate body at opposite ends of the bladder. The bladder includes an outer sealing element which, upon inflation, forms a fluid-tight seal with the cervix, and an inner sleeve which fits over the opening preventing a return flow of air, yet allowing pressurized air into the bladder for inflating it.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority under 35 U.S.C. § 371 to PCTInternational Application Number PCT/IB02/00504 filed Feb. 20, 2002,which claims priority to RSA Patent Application 2001/1415 filed Feb. 20,2001.

FIELD OF INVENTION

THIS INVENTION relates to a uterine manipulator device.

It relates particularly to a uterine manipulator device for injecting avisualisation fluid into the uterus of a female via the cervix. It alsorelates to a sealing device for use with the uterine manipulator device.

According to a first aspect of the invention there is provided a uterinemanipulator device for injecting a visualisation fluid into the uterusof a female via the cervix, the uterine manipulator device comprising

an elongate body that can be inserted into the uterus of the female viathe cervix, the elongate body having a visualisation fluid conduit alongwhich the visualisation fluid can be conveyed to the uterus and a gasconduit along which a gas can be conveyed, the gas conduit defining anoutlet opening for the gas;

gripping means that is connected to the elongate body, for releasablygripping the cervix; and

sealing means that is locatable, in use, in the cervical canal of thefemale and that is in the form of an inflatable bladder of resilientlydeformable material having two ends and defining an opening at each end,the bladder being mounted to the elongate body in an arrangement whereinthe bladder surrounds a part of the elongate body, with the elongatebody extending through the openings of the bladder and the ends thereofbeing secured to the elongate body to form a fluid-tight seal therewith,the bladder comprising an outer inflatable sealing element and an innervalve element in the form of a sleeve which extends inwardly from one ofthe ends of the bladder, terminating short of the other end thereof, thesleeve fitting over the outlet opening of the gas conduit so as to forma gas-tight seal preventing a return-flow of gas into the gas conduitfrom the bladder, the sleeve being resiliently deformable under theforce of a pressurised gas flowing in the gas conduit, in use, so as toallow the flow of gas into the bladder for inflating it to form afluid-resistant seal between the elongate body and the wall of thecervical canal, in use, thereby preventing a return-flow ofvisualisation fluid.

The outer inflatable sealing element may be substantially elongate andtubular in the inflated state.

The outer inflatable sealing element may have a configuration permittingit to conform substantially to the wall of the cervical canal in theinflated state.

The elongate body may comprise a main body portion and a nose portionthat can be inserted into the cervix, the elongate body defining saidgas conduit, with the outlet opening thereof being disposed in a regionof the nose portion surrounded by the bladder.

The gripping means may be in the form of a tanaculum.

According to a second aspect of the invention there is provided asealing device for use with a uterine manipulator device for injecting avisualisation fluid into the uterus of a female via the cervix, whereinwherein the uterine manipulator device includes an elongate body thatcan be inserted into the uterus of the female via the cervix, theelongate body having a visualisation fluid conduit along which thevisualisation fluid can be conveyed to the uterus and a gas conduitalong which a gas can be conveyed, the gas conduit defining an outletopening for the gas, the sealing device being locatable, in use, in thecervical canal of the female and being mountable on the elongate body soas to form a fluid-resistant seal between the elongate body and the wallof the cervical canal thereby to prevent a return flow of visualisationfluid, the sealing device comprising an inflatable bladder ofresiliently deformable material having two ends and defining an openingat each end, the bladder being mountable to the elongate body in anarrangement wherein the bladder surrounds a part of the elongate bodyhaving said outlet opening for the gas conduit, with the elongate bodyextending through the openings of the bladder and the ends thereof beingsecured to the elongate body to form a fluid-tight seal therewith, thebladder comprising an outer inflatable sealing element and an innervalve element in the form of a sleeve which extends inwardly from one ofthe ends of the bladder, terminating short of the other end thereof, thesleeve fitting over the outlet opening of the gas conduit so as to forma gas-tight seal preventing a return-flow of gas into the gas conduitfrom the bladder, the sleeve being resiliently deformable under theforce of a pressurised gas flowing in the gas conduit, in use, so as toallow the flow of gas into the bladder for inflating it to form saidfluid-resistant seal between the elongate body and the wall of thecervical canal, in use.

The outer inflatable sealing element may be substantially elongate andtubular in the inflated state.

The outer inflatable sealing element may have a configuration permittingit to conform substantially to the wall of the cervical canal in theinflated state.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features of the invention are described hereinafter by way of anon-limiting example of the invention, with reference to and asillustrated in the accompanying diagrammatic drawings. In the drawings:

FIG. 1 shows a schematic side view of a uterine manipulator device inaccordance with the invention;

FIG. 2 shows a schematic top view of the uterine manipulator device ofFIG. 1;

FIG. 3 shows a schematic rear end view of the uterine manipulator deviceof FIG. 1;

FIG. 4 shows a schematic side view of the extension element of theuterine manipulator device of FIG. 1;

FIG. 5 shows a schematic side view of the connector of the uterinemanipulator device of FIG. 1;

FIG. 6 shows a shows a schematic side view of the nose element of theuterine manipulator device of FIG. 1;

FIG. 7 shows a schematic side view of the bladder of the uterinemanipulator device of FIG. 1, showing hidden detail;

FIG. 8 shows an enlarged schematic sectional side view of the noseportion of the uterine manipulator device of FIG. 1, having a bladdermounted thereon, the bladder being uninflated; and

FIG. 9 shows an enlarge schematic sectional side view of the noseportion of the uterine manipulator device of FIG. 1, having a bladdermounted thereon, the bladder being inflated.

DESCRIPTION OF THE PREFERRED EMBODIMENT

With reference to the drawings, a uterine manipulator device, inaccordance with the invention, is designated generally by the referencenumeral 10. The uterine manipulator device 10 is specifically adaptedfor performing a laparoscopy wherein the device is used to inject avisualisation fluid into the uterine cavity of a female via the cervixand to manipulate the uterus for enhancing visualisation of thestructures of the uterus.

The uterine manipulator device 10 comprises, broadly, an elongate body12 having a main body portion 14 and a nose portion 16 that is insertedinto the cervix, in use, gripping means in the form of a tanaculum 18,for releasably gripping the cervix and sealing means in the form of adisposable bladder 20 for forming a fluid-resistant seal between thenose portion 16 and the cervix.

The elongate body 12 and the gripping arm 18 are of grade 316 stainlesssteel, whereas the bladder is of resiliently deformable polyurethaneplastics material. The elongate body 12 has a front end 17 and rear end19.

The tanaculum 18 comprises an arm 22 having a hook-like member 24 at oneend that hooks, in use, onto the outer cervical lip of the wall of thecervix, and a handle 26 at the other end, for manipulating the hook-likemember 24. The handle 26 defines an aperture 28 in which a finger of aperson using the device can be received for manipulating the hook-likemember 24 in scissors-fashion. The arm 22 is pivotally connected via apivot pin 30 of a pivot mounting 32, to the main body 14. The main bodyportion 14 includes a catch formation 34 near the rear end thereof forreleasably holding the arm 22 in a closed position wherein the hook-likemember 24 hooks into the cervical lip of the wall of the cervix, in use.

The elongate body 12 has a first conduit 35 along which a visualisationfluid can be conveyed into the uterus of a female, in use. The flowdirection of the visualisation fluid along the first conduit is shown bythe arrows in FIGS. 8 and 9 of the drawings. The elongate body 12 has asecond conduit 37 which can be connected to a pressurised air supply andalong which pressurised air can flow for inflating the bladder as willbe explained in further detail below.

The nose portion 16 of the elongate body includes a nose element 36, anextension element 38 and a connector 40 for connecting the nose elementand the extension element. The nose element is connected to the mainbody portion 14 of the elongate body. The connector defines an internalscrew thread formation and the nose element and the extension elementdefine complementary external screw thread formations at connecting endsthereof thereby permitting the nose element and the extension element tobe screwed into the connector 40. The screw thread formations aredesigned so as to provide a fluid-tight seal between the connector andthe nose element and the extension element, respectively.

The connector 40 defines an outlet opening 42 which is in flowcommunication with the first conduit 35 and through which visualisationfluid can flow into the uterus of a female, in use.

The nose element 36 defines an outlet opening 44 which is in flowcommunication with the second conduit 37 and through which pressurisedair can flow into the bladder 20 for inflating it. The second conduit 37comprises a tubular passage 39 which extends along the length of themain body portion and thereafter becomes an annular passage 41 in thenose element 36, the annular passage surrounding the first conduit 35and which opens into the outlet opening 44.

The bladder 20 is mounted to the nose element 36 over the outlet opening44. The bladder 20 has two ends 46 and 48 which each define an openingin which the nose element is received. The ends of the bladder aresecured to the nose element 36 so as to form a fluid-tight sealtherewith, More particularly, the end 48 defines an O-ring seal 49 whichis secured around the nose element. The end 46 defines a tapered tubularsection 50 which is clamped between the connector 40 and the noseelement as is illustrated in FIGS. 8 and 9. As such, the connector 40and the nose element define complementary tapered formations defining agap between them in which the tubular section 50 of the bladder isreceived and clamped.

The bladder 20 includes an outer inflatable sealing element 52 which,when inflated, conforms to the shape of the cervix forming afluid-resistant seal therewith. Further, the bladder 20 includes aninner valve element 54 in the form of a sleeve which extends inwardlyfrom a position near the end 48, terminating short of the other end ofthe bladder. The valve element fits over the outlet opening 44 so as toform a gas-tight seal with the nose element which prevents a return flowof air into the second conduit 37. The valve element is sufficientlydeformable to permit it to be deformed under the force of pressurisedair in the second conduit so as to allow the flow of air into thebladder for inflating it.

The invention extends to the bladder 20.

In use, in order to perform a laparoscopy on a female, the nose portionof the elongate body, having the bladder 20 mounted thereon, is insertedinto the female cervix with the extension element and the nose elementextending into the uterine cavity. In order to hold the elongate body inthis position, the tenaculum 18 is manipulated so that the hook-likemember 24 penetrates the outer cervical lip of the cervix. The handle 26is then disposed into a closed condition and releasably held in positionby the catch 34. In order to form a fluid-tight seal between the wall ofthe cervix and the nose portion of the elongate body, the second conduitis connected to an air hose and, the bladder is inflated. After anadequate seal is formed between the nose portion and the wall of thecervix, a visualisation fluid is introduced into the first conduit whereit is discharged into the uterine cavity via the outlet opening 42. Thebladder can be inflated to form a fluid-tight seal along the wholelength of the cervical canal. Being deformable, the bladder can beinflated to a required pressure so as to form a fluid-tight seal withcervixes of different sizes and lengths. Another advantage is that thebladder 20 cannot be displaced with uterine movement when the uterus ismanipulated, in use.

In another embodiment, the uterine manipulator device may have aconfiguration rendering it suitable for performing a hystosalpingogramswherein a radio opaque fluid is conveyed along the first conduit of theelongate body into the uterine cavity of a female. In this embodiment,the uterine manipulator device will be the same as that used forpreforming laparoscopies, with the only difference being that the noseportion of the elongate body is shorter than that of the uterinemanipulator device 10.

1. A uterine manipulator device for injecting a visualisation fluid intothe uterus of a female via the cervix, the uterine manipulator devicecomprising an elongate body that can be inserted into the uterus of thefemale via the cervix, the elongate body having a visualisation fluidconduit along which the visualisation fluid can be conveyed to theuterus and a gas conduit along which a gas can be conveyed, the gasconduit defining an outlet opening for the gas; gripping device that isconnected to the elongate body, for releasably gripping the cervix; andsealing device that is locatable, in use, in the cervical canal of thefemale and that is in the form of an inflatable bladder of resilientlydeformable material having two ends and defining an opening at each end,the bladder being mounted to the elongate body in an arrangement whereinthe bladder surrounds a part of the elongate body, with the elongatebody extending through the openings of the bladder and the ends thereofbeing secured to the elongate body to form a fluid-tight seal therewith,the bladder comprising an outer inflatable sealing element and an innervalve element in the form of a sleeve which extends inwardly from one ofthe ends of the bladder, terminating short of the other end thereof, thesleeve fitting over the outlet opening of the gas conduit so as to forma gas-tight seal preventing a return-flow of gas into the gas conduitfrom the bladder, the sleeve being resiliently deformable under theforce of a pressurised gas flowing in the gas conduit, in use, so as toallow the flow of gas into the bladder for inflating it to form afluid-resistant seal between the elongate body and the wall of thecervical canal, in use, thereby preventing a return-flow ofvisualisation fluid.
 2. The uterine manipulator device as claimed inclaim 1, wherein the outer inflatable sealing element is substantiallyelongate and tubular in the inflated state.
 3. The uterine manipulatordevice as claimed in claim 1 or claim 2, wherein the outer inflatablesealing element has a configuration permitting it to conformsubstantially to the wall of the cervical canal in the inflated state.4. The uterine manipulator device as claimed in any one of the precedingclaims, wherein the elongate body comprises a main body portion and anose portion that can be inserted into the cervix, the elongate bodydefining said gas conduit, with the outlet opening thereof beingdisposed in a region of the nose portion surrounded by the bladder. 5.The uterine manipulator device as claimed in any one of the precedingclaims, wherein the gripping means is in the form of a tanaculum.
 6. Asealing device for use with a uterine manipulator device for injecting avisualisation fluid into the uterus of a female via the cervix, whereinthe uterine manipulator device includes an elongate body that can beinserted into the uterus of the female via the cervix, the elongate bodyhaving a visualisation fluid conduit along which the visualisation fluidcan be conveyed to the uterus and a gas conduit along which a gas can beconveyed, the gas conduit defining an outlet opening for the gas, thesealing device being locatable, in use, in the cervical canal of thefemale and being mountable on the elongate body so as to form afluid-resistant seal between the elongate body and the wall of thecervical canal thereby to prevent a return flow of visualisation fluid,the sealing device comprising an inflatable bladder of resilientlydeformable material having two ends and defining an opening at each end,the bladder being mountable to the elongate body in an arrangementwherein the bladder surrounds a part of the elongate body having saidoutlet opening for the gas conduit, with the elongate body extendingthrough the openings of the bladder and the ends thereof being securedto the elongate body to form a fluid-tight seal therewith, the bladdercomprising an outer inflatable sealing element and an inner valveelement in the form of a sleeve which extends inwardly from one of theends of th bladder, terminating short of the other end thereof, thesleeve fitting over the outlet opening of the gas conduit so as to forma gas-tight seal preventing a return-flow of gas into the gas conduitfrom the bladder, the sleeve being resiliently deformable under theforce of a pressurised gas flowing in the gas conduit, in use, so as toallow the flow of gas into the bladder for inflating it to form saidfluid-resistant seal between the elongate body and the wall of thecervical canal, in use.
 7. The sealing device as claimed in claim 6,wherein the outer inflatable sealing element is substantially elongateand tubular in the inflated state.
 8. The sealing device as claimed inclaim 6, wherein the outer inflatable sealing element has aconfiguration permitting it to conform substantially to the wall of thecervical canal in the inflated state.